IPX-203 as a Parkinson Disease Treatment: Alberto J. Espay, MD, MSc

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“It was accomplished, from the standpoint of the study design, to reduce the number of doses, and I think that’s in and of itself important, but if you factor in clinical practice, it’ll be important to reduce the OFF times, or, ideally, eliminate it. You can conceive that with IPX-203.”

Amneal Pharmaceuticals is evaluating an investigational therapy for the treatment of Parkinson disease, known as IPX-203. In August, positive topline results the phase 3 clinical trial, RISE-PD (NCT03670953), showed that it may have potential for individuals with Parkinson disease (PD) who experience motor fluctuations. The trial was conducted at 108 clinical sites in the US and Europe and randomized 506 patients with PD aged 40 years and older. Currently, a 9-month safety extension study is ongoing.

In the study, the IPX-203 group demonstrated greater good ON time from baseline after the 13-week double-blind treatment period compared with a group of patients on immediate-release carbidopa/levodopa (CD/LD). Ultimately, treatment with the investigational oral CD/LD extended-release capsules resulted in 0.53 more hours of good ON time than immediate-release CD/LD (P = .0194), when compared with baseline. Based on the results and other supportive data it holds, Amneal noted that it plans to submit a new drug application for IPX-203 with the FDA in mid-2022.

NeurologyLive spoke with investigator Alberto J. Espay, MD, MSc, professor of neurology, director, James J. and Joan A. Gardner Family Center, and research chair, Parkinson’s Disease and Movement Disorders, University of Cincinnati Health, to learn more about the data from the trial. He offered his thoughts on the efficacy of the therapy and his perspective on the data.

REFERENCE
Amneal Announces Positive Topline Results from Pivotal Phase 3 RISE-PD Clinical Trial of IPX-203 in Patients with Parkinson’s Disease Who Experience Motor Fluctuations. News relase. Amneal Pharmaceuticals. August 25, 2021. Accessed October 12, 2021. https://www.businesswire.com/news/home/20210825005679/en/Amneal-Announces-Positive-Topline-Results-from-Pivotal-Phase-3-RISE-PD-Clinical-Trial-of-IPX-203-in-Patients-with-Parkinson%E2%80%99s-Disease-Who-Experience-Motor-Fluctuations